Cyclosporin greatly improves the quality of life of adults with severe atopic dermatitis. A randomized, double-blind, placebo-controlled trial

Abstract

A multicentre, randomized, double-blind, controlled crossover clinical trial was conducted on 33 patients with severe refractory atopic dermatitis, to determine the effects of cyciosporin (5 mg/kg/day) on their health-related quality of life. Treatments were administered for 8-week periods. One group (n=16) received placebo followed by cyclosporin, and the other (n=17) received cyclosporin and then placebo. Health-related quality of life was assessed at o, 8 and 16 weeks using a general measure, the United Kingdom Sickness Impact Profile (UKSIP), an eczema-specibic measure, the Eczema Disability Index (EDI), and a global 5-point rating scale of overall health (very good to very poor). In addition, clinical assessments (i.e. extent and activity of disease) were made by the investigators. UKSIP and EDI scores indicated significant improvement in quality of life (P<0.05–P<0.01) of patients with atopic dermatitis after treatment with cyclosporin. Although no patient required withdrawal from the study. 20 patients receiving cyclosporin reported adverse events, compared with eight taking placebo. There was a close correlation (P<0.05–P<0.01) between the UKSIP and HDI scores. In contrast, there was either no correlation, or only a very poor correlation, between the quality of life parameters and clinical measures of extent and activity of eczema. When cyclosporin was stopped, relapse was rapid, but the mean scores for disease activity and extent of disease were less than their baseline values (i.e. an improvement of greater than 25% was maintained in 11 patients at week 4). However, there was no relapse in the overall quality of life scores 8 weeks after cyclosporin was withdrawn, contrary to what was seen when only the skin signs were assessed. Short-term treatment with cyclosporin has beneficial effects on the quality of life of patients with severe, refractory atopic dermatitis, and may be a valuable alternative to short courses of systemic steroids, giving patients a much needed period of remission that provides prolonged quality of life benefit in some patients. Quality of life can be successfully assessed in patients with atopic eczema using the UKSIP and the EDI.